cRCT of AI Agent in Clinital Resoning Training

NCT07624682 | Enrolling By Invitation

• 1 other identifier: K10357
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional medical education has long emphasized one-way transmission of theoretical knowledge, which presents limitations in the systematic cultivation of clinical reasoning skills among medical students. Miller's pyramid of clinical competence emphasizes the gradual transformation from theoretical knowledge to clinical practice ability. Case-based learning (CBL), as a teaching method centered on real or simulated clinical cases, is a key strategy to address the above limitations. Artificial intelligence (AI)-assisted clinical reasoning training tools can overcome time and space constraints, and offer students repeatable, adaptive, and real-time feedback case training, thereby reinforcing the sustained role of CBL in clinical reasoning development. Currently, it still lacks high-quality evidence from randomized controlled trials on the impact of AI agents on medical students' clinical reasoning skills. This study plans to evaluate the impact of an AI clinical reasoning training agent on students' clinical reasoning training outcomes and CBL learning experience. Primary Objective: To evaluate the impact of the AI agent on student learning outcomes (course examination scores and clinical reasoning test scores). Secondary Objective: To investigate students' AI acceptance (perceived usefulness, perceived ease of use, satisfaction, and intention to use). This study adopts a two-arm parallel cluster randomized controlled trial design. The trial is designed and reported in accordance with the CONSORT statement. The study population will recruit Class of 2021 medical students (8-year program) from Peking Union Medical College and Class of 2020 medical students (8-year program) from Tsinghua University School of Medicine. Both cohorts are officially enrolled in the "Comprehensive Clinical Course" for the 2025-2026 academic year, have consistent foundational knowledge in basic medicine and diagnostics, and are in the phase of clinical medicine theory learning, not yet having entered clinical practice. Using PASS 2025 software, the sample size per arm for the cRCT is 39, with number of clusters per arm K=N/M =13, Considering a 10% attrition or exclusion rate, the target recruitment is 88 participants. Considering potential heterogeneity in baseline between students from the two schools, and possible contamination due to discussions among dormitory mates during the intervention, this study will adopt stratified cluster randomization, first stratifying by school, then using dormitory as the smallest randomization unit. Dormitories will be sorted by the random number, with the first half allocated to the intervention group and the second half to the control group. Participants' group assignment will be revealed via unique student ID only after baseline data collection and informed consent are completed. This study will select five topics from the "Comprehensive Clinical Course": "Infectious Diarrhea," "Viral Hepatitis," "Bloodstream Infection," "Infective Endocarditis," and "Central Nervous System Infection". Standardized cases will be provided by the teaching faculty, with two cases per topic, totaling 10 cases. These cases will be used to train AI agent. After class, the AI agent training tasks will be sent to the intervention group, and study materials will be distributed to the control group. Course examination scores and clinical reasoning test scores are the primary outcomes. AI technology acceptance including perceived usefulness, perceived ease of use, satisfaction, and intention to use are the secondary outcomes. This study has been approved by the Research Ethics Committee of Peking Union Medical College Hospital (Approval No.: I-26PJ0851).

Conditions

Medical Education; Clinical Reasoning; AI Agent

Keywords

medical education; clinical reasoning; AI agent; AI-assisted education

Outcome Measures

Primary Outcomes (2)

• Course examination scores

  The examination includes 8 of A1 multiple choice questions (MCQs), 8 of case summary MCQs, 2 of A3 case-cluster MCQs, 3 A4 case-series best-answer MCQs, and 1 of case analysis questions, with a total score of 25. All test questions are provided by the teaching faculty, covering core diseases from the five topics. The questions will reviewed by the same two senior clinical faculty members to ensure appropriate case selection and difficulty.

  One week after the course

• Clinical reasoning test score

  The test is designed based on a case of infective endocarditis (IE) and is supposed to be accomplished in 30 min. There are five questions in total. Information and questions will be presented step by step, with a total score of 25.

  One month after the course

Secondary Outcomes (1)

• AI technology acceptance

  Immediately after the clinical reasoning test

Study Arms (2)

intervention group (AI Agent)

EXPERIMENTAL

Other: AI agent

control group (study materials)

EXPERIMENTAL

Other: Study materials

Interventions

AI agent OTHER

AI agent tasks for clinical reasoning training

intervention group (AI Agent)

Study materials OTHER

Study materials including case information, questions, and answer keys

control group (study materials)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• full-time registered and enrolled in the "Comprehensive Clinical Course"
• signed informed consent, voluntary participation in this study and completion of relevant tests and questionnaires

You may not qualify if:

• · planned suspension of studies, withdrawal, or major transfer during the study period

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (3)

• Leyrat C, Eldridge S, Taljaard M, Hemming K. Practical considerations for sample size calculation for cluster randomized trials. J Epidemiol Popul Health. 2024 Feb;72(1):202198. doi: 10.1016/j.jeph.2024.202198. Epub 2024 Feb 13.

  PMID: 38477482 BACKGROUND

• Miller GE. The assessment of clinical skills/competence/performance. Acad Med. 1990 Sep;65(9 Suppl):S63-7. doi: 10.1097/00001888-199009000-00045. No abstract available.

  PMID: 2400509 BACKGROUND

• Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.

  PMID: 40228833 BACKGROUND

Related Links

• Case-Based Learning in Medical Education

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: June 3, 2026
• Study Start: April 1, 2026
• Primary Completion: May 8, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

CN (1)